FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine

Metastatic Pancreatic Cancer Clinical Trial

— FIRGEMAX  

Official title:

Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827201
• Other study ID #: PRODIGE 37
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: March 2021

Study information

• Verified date: August 2022
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: March 2021
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histological or cytological confirmation of pancreatic adenocarcinoma

• Distant metastatic disease

• Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment

• At least one lesion measurable by RECIST v1.1 criteria

• Life expectancy> 3 months

• No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)

• No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)

• Pain must be monitored before inclusion

• 18 years < age < 75

• Performance status: WHO < 2

• ANC = 1500/mm3, platelets = 100 000/mm3, haemoglobin = 9 g/dL

• ASAT (SGOT), ALAT (SGPT) = 2.5 x ULN or = 5 x ULN if liver metastases found

• Bilirubin = 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 µmol/L, or MDRD creatinine clearance > 60 mL/min

• Women of childbearing age must have a negative pregnancy test (ß HCG) before starting treatment

• Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose

• Patient affiliated to the social security scheme

• Patient information and signature of informed consent

Exclusion Criteria:

• - Other types of pancreatic tumours, especially endocrine or acinar cell tumours

• Ampulloma

• Presence of meningeal or cerebral metastases, bone metastases

• Gilbert's syndrome

• Presence of neuropathy> grade 1 according to NCIC-CTC 4.0

• Contraindications specific to the studied treatments

• History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered

• Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured

• Significant history of heart or respiratory disease, including any history of interstitial pneumonia

• Patient already included in another clinical trial with an experimental molecule

• Women who are breast-feeding

• Persons deprived of liberty or under guardianship

• Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• FOLFIRI.3
For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
• nab-paclitaxel+ gemcitabine
For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

Locations

Country	Name	City	State
France	Clinique Privée Claude Bernard	Albi
France	CH	Blois
France	Clinique Tivoli Ducos	Bordeaux
France	Hôpital Duchenne	Boulogne sur Mer
France	CH Pierre Oudot	Bourgoin-Jallieu
France	Centre François Baclesse	Caen
France	CHR côte de Nacre	Caen
France	Centre Hospitalier Sud Francilien	Corbeil Essonnes
France	Centre GF Leclerc	Dijon
France	CH de la Dracénie	Draguignan
France	Ch Jacques Monod	Flers
France	CH	Frejus
France	CHU	Le Kremlin Bicetre
France	CH	Le Mans
France	CHU	Limoges
France	Clinique Chenieux	Limoges
France	CH	Longjumeau -
France	CH Pierre Benite	Lyon
France	Hopital Europeen Marseille	Marseille
France	H Layné	Mont-de-Marsan
France	HEGP	Paris
France	Hôpital Cochin	Paris
France	Hôpital La Pitié Salpêtrière	Paris
France	CH St Jean	Perpignan
France	Hôpital Haut Lévèque	Pessac
France	Centre Cario - Hpca Saint Brieuc	Plérin
France	Hôpitaux Drome Nord	Romans Sur Isere
France	CHU	Rouen
France	CHP	Saint Grégoire
France	Clinique Privée	Strasbourg
France	Hopitaux Du Leman	Thonon Les Bains
France	Clinique Pasteur Groupe ONCORAD GARONNE	Toulouse
France	Clinique Privée Pasteur	Toulouse
France	Clinique Privée Saint Jean	Toulouse
France	Clinique St Jean Languedoc	Toulouse
France	Gustave Roussy	Villejuif
France	Hôpital Paul Brousse	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive	GERCOR - Multidisciplinary Oncology Cooperative Group, UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients alive without progression 6 months after inclusion	The progression is clinically and/or radiologically assessed by the investigator (as defined in 1.1) according to RECIST v1.1 criteria.	6 months
Secondary	Overall survival (OS):	Time interval between the randomisation date and the date of death (all causes). The patients alive will be censored at the end-point or the date of the latest event	1 and 2 years
Secondary	Objective response rate (ORR)	Complete or partial response rates in imaging by RECIST v1.1 over the entire treatment period according the investigator	6 months
Secondary	Progression-free survival:	Time interval between the randomisation date and the date of first progression (clinical and/or radiological) or death (whatever the cause). Living patients without progression will be censored at the end-point or date of latest event.	1 and 2 years